FDA Registration
Active
🇺🇸 United States
PFMMedical6614 (TM) - Jet-Vac Drainage Line Extension (Ref M7097)
Reg #: 1047843
·
FEI: 1047843
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ISOMEDIX OPERATIONS INC.
- Registration Number
- 1047843
- FEI Number
- 1047843
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2072 SOUTHPORT RD., HWY. 295
- City
- SPARTANBURG
- State
- SC
- ZIP
- 29306
- Country
- US
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 1527821
- Address
- 5960 Heisley Rd, --
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2012-12-27 |
Proprietary Names
PFMMedical6614 (TM) - Jet-Vac Drainage Line Extension (Ref M7097)
PFMMedical6614 (TM) - ASEPT Drainage Line Set (Ref M7005)
PFMMedical6614 (TM) - ASEPT Replacement Valve (Ref M7004)
PFMMedical6614 (TM) - Jet-Vac Drainage Line (Ref M7099)
PFMMedical6614 (TM) - Jet-Vac Large Bore Drainage Line Set (Ref M7098)
Ace1454 (NR) - ACE Stopcocks; ACE Valves
PFMMedical6614 (TM) - ASEPT Power Flush Adaptor
Prava (LSRTC) - UGARing
Ursel11054 (MN) - Posi-Stick Introducer Set
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)